Document Sample
					                      rOME fOUNDATION
Volume 4, Issue 1, Spring 2011                                                                           Rome Foundation Newsletter

                       President’s Report
                       Douglas A. Drossman, MD
                       President, Rome Foundation
                       Senior Editor, Rome III Book

                         It is again a pleasure to send you our     Regulatory Agency attended; we are hopeful that this meeting
                         biannual newsletter an update on the       will spur interest in the development of standards for multi-
                         Rome Foundation’s activities. There has    national research, just as the Foundation has provided guidance
                         been considerable growth and some new      for diagnostic criteria and endpoints and outcomes in clinical
initiatives which I am pleased to present.                          trials. The presentations and supplementary material will soon
                                                                    be available on our website (
In our effort to stay connected to the field, thanks to Michele     Of course we continue to hold educational programs at United
Pickard our administrator, we have set up a program for             European Gastroenterology Week (UEGW) and at venues in
“Associates of Rome” and to date we have 54 associates from         Eastern Europe, Latin American and Asia. Most recently the Asian
22 countries. These individuals, most of whom are in academic       Working Team for Functional GI Disorders (Kok Ann Gwee MD,
positions in their countries are afforded closer communication      PhD –Singapore, Chair, William E. Whitehead PhD –USA, Co-Chair)
with Rome Foundation activities, discounts on functions and         with representatives from 6 Asian countries convened at the
educational products and open access to our newsletters and         Asian Neurogastroenteroogy and Motility Association in Beijing
other materials.                                                    to begin a multi-national survey of the prevalence of FGIDs in the
                                                                    clinical setting. This information will be used to help develop or
We continue to grow our association with the American               modify existing criteria that will be of value to studies involving
Gastroenterological Association. This includes a co-marketing       the Asian community.
arrangement to provide some of our educational products
and a collaboration on several learning initiatives for AGA         Our Working Teams remain active and The Role of Intestinal
members. Perhaps one of the more exciting one is to develop         Microbiota in Functional GI Disorders (Magnus Simren MD –
a 1½ day communication skills workshop designed to manage           Sweden, Chair; Giovanni Barbara PhD – Italy, Co-Chair) is more
difficult clinical scenarios and to enhance the patient-physician   than halfway through the process and expect to submit their
relationship in caring for patients with FGIDs.                     review of the field and recommendations for research later this
                                                                    year. After a 2 year hiatus to complete additional research, the
We have also expanded our translations of educational materials     Severity in IBS (Doug Drossman MD – USA, Chair; Lin Chang MD
into many languages and have begun several global educational       - USA Co-Chair) has completed their work and the manuscript is
and research programs. Dr. Ami Sperber (Israel) has taken           currently under review. Two new important working teams under
forwarded our efforts to provide international availability for     development include one on Food and Diet (William Chey MD –
our questionnaires and criteria and currently there are over 16     USA, and Jan Tack, MD, PhD – Belgium, Co-Chairs) and another
translations completed or underway, and our Rome III book is        on Multi-National Cross Cultural Research in the FGIDs (Ami
now published in Chinese, Japanese and Spanish. Our publication     Sperber MD – Israel, Chair). The information provided by these
of the Rome Foundation Algorithms for Common GI Symptoms in         committees will be well timed for the Rome IV committees to use
the American Journal of Gastroenterology in April, was replicated   in their work on building the new chapters.
thanks to the efforts of Dr. Max Schmulson (Mexico) into Spanish
and published in the Mexican Journal of Gastroenterology this       Lin Chang, MD (USA) continues to chair our educational activities
past November.                                                      and possibly the highlight this year will be the 4th Annual Rome
                                                                    Foundation – AGA Institute Lecture at DDW. We will have two
With regard to global education, the Rome Foundation sought         speakers for this session to be held on Sunday, May 8 from 10:30
collaboration in association with the World Gastroenterology        – noon in Room E 451B in the Chicago convention Center. Both
Organisation (WGO) produced a multi-national conference             speakers are from Columbia University in NYC, and they will
on cross-cultural research and care in IBS. “IBS – The Global       be presenting on the brain and gut aspects of neurogenesis.
Perspective” which was held at the Pfister Hotel in Milwaukee,      Tarique Perera MD will speak on “The Role of Neurogenesis in
WI on April 6-7 just prior to the IFFGD International Conference    the Brain” and Michael D. Gershon MD will discuss “The Role of
on Functional GI disorders. This conference provided the venue      Neurogenesis in the Enteric Nervous System” as related to the
for understanding IBS from a multinational and multi-cultural       Functional GI Disorders.
perspective. This information will continue to be of interest to
academicians, clinicians, industry representatives and regulatory   Our research program under the direction of Bill Whitehead,
agencies. Representatives from the FDA, EMEA and the Japan          PhD (USA), has finalized the selection of our Rome Foundation
                                                                                                                      continued on page 2

                                                  www . theromefoundation . org
Program and Project uPdates

     continued from page 1

     Research Award and our Ray Clouse Prize for the Best Research
     in the FGIDs along with a new award, the Ray Clouse Award                    Planning for Rome IV
     for Paper Most Cited in Functional GI and Motility Disorders.
     The awards will be presented at our annual reception at DDW
     on Saturday evening at 6 PM in Chicago.                                      The Rome Foundation is beginning to plan for Rome IV.
                                                                                  This will be an update of knowledge of the functional
     The most exciting news to report is that the Rome IV process                 GI disorders with the inclusion of new diagnostic
                                                                                  criteria. There are several new features that are worth
     has just begun. An editorial board will be in place by DDW in                noting. First, careful attention is being paid to produce
     May and there will be several new and exciting initiatives that              the most needed information for this publication. A
     will help carry the field of FGIDs forward.                                  planning committee will select the Editorial board
       • Publication will be delayed to 2015-2016. This will                      and make recommendations for the publication
         permit the use of support committees that will be                        content. The editorial board will have an active role
         charged to provide new information that will help the                    in selecting the committee chairs, coordinating the
                                                                                  publication, and each board member will serve as
         Rome IV committees in their work. The committees                         a liaison with one or two chapter committees to be
         will include those doing systematic reviews and meta-                    sure there is consistency in the work effort across
         analyses, working on cross-cultural aspects of the                       chapters. Standards for selecting chapter committee
         FGIDs, and looking at the application of the information                 members will based on academic credibility will be
         in primary care and others.                                              maintained.
       • We plan to focus more on online access to the                            Another new feature will be a delay in the publication
         information by computer or iPad. For a subscription,                     date. While in the past the publication sequence from
         individuals will be able to free text search for                         Rome I, to II to III had been 6 years, it is expected that
         information or download chapters or the entire                           the Rome IV will be published late 2015 or early 2016,
         book. Of course hard copies of the book and a journal                    about 10 years after the Rome III book in 2006. The
         supplement containing abridged information will be                       main reason is to allow enough time for new data to
         available as usual.                                                      accumulate that will be used by the Rome IV chapter
                                                                                  committees. In addition there will be several “support
       • In keeping with our efforts to disseminate information                   committees” activated to facilitate the provision of
         globally we will work to provide simultaneous                            new knowledge that will be made available for the
         translation of the chapter material at the time of or                    chapter committees to use in their work. This will
         soon after publication of Rome IV                                        include many of the existing and newly developed
                                                                                  working teams on severity, intestinal microflora, cross-
       • The content will be expanded to include more                             cultural aspects (Asian working team) and food and
         information on Women’s Health, biomarkers and                            nutrition. In addition we expect to set up a committee
         global aspects of research and patient care                              of experts to do meta-analyses for the committees, as
       • We also plan to develop products derived from this                       well as a committee to make recommendations for
         content that is more portable. This will include pocket                  multi-national research. As a result the chapters to
                                                                                  come out for Rome IV will have new information to
         information on the criteria, a primary care version and                  help in their recommendations.
         products for use by our sponsors.
       • Finally, we recognize that the diagnostic criteria while                 We are also looking to improve the distribution of
         helpful for recruitment into research studies, do not                    this new knowledge. Rome IV will be accessible
                                                                                  electronically by text searching or downloading of
         fully capture the spectrum of the patient within the                     sections, chapters or the entire book, in addition to
         clinical context. Accordingly we plan to develop a multi-                hard copy availability. We plan to have simultaneous
         dimensional clinical profile classification in addition                  translation of the book into several languages at
         to the diagnostic criteria, which will encompass                         the time of publication or soon thereafter. Ceciel
         aspects of severity and disability, level of physiological               Rooker, managing editor and public relations director
         dysfunction and psychosocial co-morbidity.                               will be working with the committees to produce
                                                                                  “deliverables” that can be distributed by sponsors
     Our mission: “To improve the lives of people with functional                 to clinicians. This may include smaller brochures or
                                                                                  information cards for example of the criteria that
     GI disorders” and our three goals, to: “promote clinical                     can fit in a lab coat. Finally, we plan to have multiple
     recognition and legitimization of the functional GI disorders”,              “launches” at major GI meetings in the US and with
     “develop a scientific understanding of their pathophysiological              the help of our International Liaison Committee at
     mechanisms” and “optimize clinical management for patients                   major international conferences.
     with FGIDs” continue to drive all activities. We are grateful for
     our 14 industry sponsors and look forward to working with you
     to advance the field of FGIDs.                                               We are hopeful that Rome IV will be a welcome
                                                                                  addition to investigators, clinicians, regulatory
                                                                                  agencies and our industry sponsors. Stay tuned.

                                                                                  Douglas A. Drossman, MD
                                                                                  Senior Editor

 2                                                                    r ome foundation
                      r ome f ounDaTion B oarD                                of   D irecTors

                                          Douglas A. Drossman, MD
                                            Chapel Hill, NC USA

         Fernando Azpiroz, MD, PhD                                            Robin Spiller, MD, MSC
              Barcelona, Spain                                                 Nottingham, England
                  Lin Chang, MD                                                 Jan Tack, MD, PhD
               Los Angeles, CA USA                                               Leuven, Belgium
                William D. Chey, MD                                      Nicholas J. Talley, MD, PhD
                Ann Arbor, MI, USA                                        Newcastle, NSW, Australia
           John Kellow, MD, FRACP                                         William E. Whitehead, PhD
           New South Wales, Australia                                        Chapel Hill, NC, USA

                                   O ur missiOn is :
    “T o   i m prove T he lives of p eo pl e w i Th f u n cTi o n a l                   Gi D i s o rDer s .”

                                      rome founDaTion aDminisTraTion
           Executive Director                  Administrator                          Medical Illustrator
           William N. Hilliard, Jr.            Michele Pickard                        Jerry Schoendorf
           Raleigh, NC, USA                    Chapel Hill, NC, USA                   Chapel Hill, NC, USA

           Public Relations                    Sarah Barrett                          Website/Newsletter Design
           Ceciel Rooker                       Administrative Assistant for           Ceara Owre
           Chapel Hill, NC, USA                Public Relations                       Chapel Hill, NC, USA
                                               Chapel Hill, NC, USA

                                           t able      of   c ontents
Program and Project UPdates                                    meeting and events
Presidents rePort                                 1            meet the exPerts at uegw 2011                      12
education rePort                                  4            iBs - the gloBal PersPective                       13
welcome new executive director                    4            rome foundation/aga lectureshiP
rome translation Project                          5                 at ddw 2011                                   14
rome foundation research Program                  6
rome foundation working team                      10           annoUncements
associates of rome                                11           iffgd uPdate                                       15
                                                               rome foundation legal counsel                      17
                                                               rome and aga collaBoration                         18
                                                               rome criteria reference list                       19

                                           www . theromefoundation . org                                               3
Program and Project uPdates

                                     Rome Foundation Educational Program

                                     Lin Chang, MD
                                     Chair, Education Committee

     There are both continuing and new educational programs that            of Neurogenesis in the Brain and Gut and its Implications for
     the Rome Foundation has been working on. These include the             Functional GI and Motility Disorders. Dr. Perera is an Assistant
     Rome educational slide sets on FGIDs, the annual Rome-AGA              Professor in Clinical Psychiatry will discuss the suppression of
     lectureship at Digestive Diseases Week (DDW), and a Best of            neurogenesis in the brain, specifically the hippocampus, and
     DDW FGID abstract webcast.                                             its role in increasing the vulnerability to developing depression.
                                                                            Dr. Perera’s work has important implications for functional
     Rome educational slide sets                                            gastrointestinal disorders (FGIDs) because of their overlap with
     The Computer-Based Learning Program includes state-of-the-art          depression and that antidepressants, which restore and stimulate
     slides that brings to life information from the Rome III book on       neurogenesis, are frequently used to treat FGIDs. Dr. Gershon is an
     FGIDs. This educational program is endorsed by AGA Institute.          internationally renowed scientist who has studied microcircuits
     The slide set includes a wide range of information that spans          within the enteric nervous system and their regulation of motor,
     from epidemiology to pathophysiology to treatment. A number            secretory and absorptive functions within the GI tract and their
     of animations, videos and conceptual slides help to communicate        relevance in functional and motility GI disorders. The Rome-AGA
     ideas that may otherwise seem difficult to convey. Notes and           lectureship will take place on Sunday, May 8, 2011 at 10:30am.
     legends for every slide give a description of the slide with key
     references.                                                            Best of DDW webcast
                                                                            Rome Foundation Board members will review and discuss the
     Fourth Annual Rome-AGA lectureship at the DDW                          best abstracts on FGIDs from this year’s DDW. Working with
     Two faculty members from Columbia University, Dr. Tarique              the GI Health Foundation on this educational endeavor, this
     Perera and Dr. Michael Gershon, will lecture at the Fourth Annual      information will be broadcast on a webcast that will be available
     Rome-AGA lectureship at this year’s DDW meeting on The Role            for viewing soon after the meeting.

                                    Welcome William (“Wink”) Hilliard Jr.
                                    Executive Director Rome Foundation

     We are grateful to Mr. George Degnon and Ms. Kathy Haynes of           including the NC Society of Anesthesiologists, the NC Society of
     Degnon and Associates for their 15 years of service and support        Internal Medicine, and the NC College of Emergency Physicians.
     to the Rome Foundation. As of January 1, the business operations       He has extensive experience in meeting management and the
     have moved from Degnon Associates to Hilliard Associates in            provision of financial services including portfolio management.
     Raleigh, NC. Mr. William (“Wink”) Hilliard Jr. will then continue as   Mr. Hilliard will represent the Foundation in its many activities,
     Executive Director of the Rome Foundation and will handle all the      coordinate sponsor related contracts, financial reports, fund
     day to day activities. Mr. Hilliard is a graduate of the University    raising and distribution of our books and educational products.
     of North Carolina in Chapel Hill and held an academic position         He can be reached at P.O. Box 6524, Raleigh, NC 27628.
     in Corporate and Divisional Strategic Planning. His experience         Phone: 919-787-5859, Fax: 919-900-7646, email: whilliard@
     has involved the management of several medical organizations 

 4                                                                 r ome foundation
                                                                                                                  Program and Project uPdates

                                     Rome Translation Project - Update

                                     Ami D. Sperber, MD, MSPH
                                     Chair, Rome Foundation
                                     Translation Project

The increasing interest in research in IBS and other functional                    The challenge of cross-cultural translation is to adapt an
gastrointestinal disorders (FGIDs) and the growing sophistication                  instrument so that it retains the meaning and intent of the
of communication technology make cross-cultural, multinational                     original instrument (the source language) and is culturally
research a feasible endeavor. Collaborative multinational, cross-                  relevant and comprehensible in the target language. Thus, the
cultural studies in FGIDs, using appropriate research methodology,                 aim is to achieve a "cultural" rather than a "literal" translation
can make a significant contribution to the understanding of FGIDs                  into a target language.
and to patient care.
                                                                                   The project has developed official guidelines for translation of
In addition, pharmaceutical companies are increasingly conduct-                    these materials that must be followed before Rome Foundation
ing trials of new drugs in numerous countries around the world.                    approval is granted. The guidelines are available for download at
The conduct of multinational research successfully requires an                     the Rome Translations Project website: www.theromefoundation.
infrastructure of study instruments validly translated into the                    org/translations/guidelines.cfm. More complete information on
languages of the study populations.                                                the translation project can be found at its homepage at: www.
                                                                          The project will both
"The Rome Translation Project", headed by Dr. Ami Sperber,                         monitor translation initiated by others and initiate translations
was established to oversee the translation of all relevant Rome                    itself. Approval is required for all uses of translated versions of
Foundation material, in particular the Rome III book, the Rome III                 the Rome material including research and education.
diagnostic questionnaire, and the Rome clinical algorithms. The
diagnostic questionnaire and criteria, in its approved language                     Approved language versions of the Rome questionnaires will be
versions, will be available for use in epidemiologic studies and                    available free of charge for academicians conducting independent
clinical trials.                                                                    studies that are not funded by pharmaceutical companies or
                                                                                                                       other commercial interests. A
                All Adult      Adult FD module    Adult IBS module                                  Psychosocial alarm request can be placed through
  Language                                                            Pediatric    Alarm questions
                Modules *        Stand-alone        Stand-alone                                        questionnaire
                                                                                                                       the translation project website.
   Arabic      To be started
                                                                                                                       In commercially funded studies
                                                                                                                       a fee will be charged for the use
   Chinese         Yes
                               Included in “All   Included in “All
                                                                         Yes              Yes                Yes
                                                                                                                       of translated questionnaires.
                               Adult Module”      Adult Module”                                                        In all events a licensing
   Dutch            No               No                 Yes              Yes
                                                                                                                       agreement will be signed
                                                                                                                       with the Rome Foundation
   French      In progress                                                           In progress        In progress
                                                                                                                       before the translated version
                                                                                                                       is provided to the investigator.
   German          Yes                                                   Yes              Yes           In progress
                                                                                                                       Dr. John Kellow will be in
                                                                                                                       charge of licensing and fee
   Hebrew          Yes
                               Included in “All   Included in “All
                                                                                          Yes                Yes
                               Adult Module”      Adult Module”
                               Included in “All   Included in “All                                                     The following table details
   Italian         Yes                                                                  Yes
                               Adult Module”      Adult Module”                                                        available language versions
                               Included in “All   Included in “All                                                     as of the moment. This is an
  Japanese         Yes                                                   Yes            Yes              Yes
                               Adult Module”      Adult Module”                                                        ongoing project with an ever-
                               Included in “All   Included in “All                                                     increasing number of available,
   Korean          Yes
                               Adult Module”      Adult Module”                                                        validated translations.
Malay-Bahasa        No               Yes                Yes                             Yes              Yes

 Norwegian          No                              In progress          Yes

 Portuguese                          Yes            To be started

                               Included in “All   Included in “All                                                     *All adult modules includes
   Spanish         Yes
                               Adult Module”      Adult Module”
                                                                         Yes            Yes              Yes           Functional Dyspepsia (FD)
                                                                                                                       module, IBS module, Alarm
    Thai            No                                               In progress                                       questions, and psychosocial
                                                                                                                       alarm questionnaire.

                                                               www . theromefoundation . org                                                               5
Program and Project uPdates

                                 Rome Foundation Research Program

                                 William E. Whitehead, PhD
                                 Chair, Research Committee

     Rome Foundation Research Award
     The Rome Foundation provides a $50,000 research grant each year to a young investigator. Preference is given to
     applications that (1) test the validity and/or utility of the Rome III diagnostic criteria, (2) assess the epidemiology of
     functional GI and motility disorders, or (3) advance knowledge of outcome assessment or trial design for FGID treatment
     trials. The applications receive an NIH-style review by an independent review committee. This year the review committee
     was chaired by Dr. Brooks Cash, Professor of Medicine at the Uniformed Services University for the Health Sciences and
     Chief of Medicine at Walter Reed Army Medical Center.

     Ray Clouse Prize for the Best Research Article on Functional Gastrointestinal
     and Motility Disorders 2010
     In 2008 the Rome Foundation created an award in memory of Ray E. Clouse, MD, a gastroenterologist and scholar at
     Washington University School of Medicine and a devoted member of the Rome Foundation. This award recognizes the
     author of the best original research paper published in the functional gastrointestinal and motility disorders for the
     calendar year preceding each DDW. While many papers are nominated by the Board of the Rome Foundation, anyone may
     submit a nomination by briefly describing how the paper will impact the field of functional gastroenterology and motility
     along with a pdf of the paper. Rome Foundation board members are ineligible. The best paper is selected by a vote of the
     Rome Foundation board.

     Ray Clouse Prize for the Most Cited Article in Functional Gastrointestinal and
     Motility Disorders 2009
     This year a new prize has been created to provide an award for the most cited original research article in functional GI and
     motility disorders for the year 2009. Papers by members of the Board of the Rome Foundation are not eligible. The two-year
     lag between the year of publication and the year the award is made reflects the fact that citations of a paper are usually
     delayed by approximately one year; by choosing a two year lag, the Rome Foundation sought to avoid disadvantaging
     papers published late in the calendar year. The most cited paper is identified by the Web of Science search engine.

 6                                                          r ome foundation
                                                                                               Program and Project uPdates

                         Rome Foundation Research Grant Award
                         2011 WINNER – Lars Agréus MD, PhD

                         Lars Agréus MD, PhD
                         Professor and Chair
                         Center for Family and Community Medicine
                         Department of Neurobiology, Care Sciences and Society
                         Karolinska Institutet/Stockholm County Council

   Lars Agréus has been a professor of family medicine since     and supplementary questionnaires in a random sample of
2007. The focus of his research is gastroenterology in primary   1001 adults. The Kalixanda Study has resulted in three PhD
care. Since September 2009, he has been head of the Center       dissertations and 19 scientific publications so far; follow-up
for Family and Community Medicine at Karolinska Institutet,      is still underway. Professor Agréus and his research group
Stockholm, Sweden.                                               have also completed a colonoscopy study that included 746
   Professor Agréus began his research career in 1987 at         randomly selected adult volunteers. The first articles about
the Department of Family Medicine, Uppsala University,           this study are in the pipeline for publication.
Sweden. In 1993, he defended his doctoral dissertation, “The        Professor Agréus has published approximately 60 scientific
Abdominal Symptom Study.” He spent a postdoctoral year at        articles, reviews, and editorials in peer-reviewed journals and
the University of Sydney in Australia studying associations      has contributed abstracts to or given lectures at numerous
between the quality of doctors’ consultations and the            scientific meetings in the field of gastroenterology. He has
outcome of dyspepsia. Subsequently, he served as a senior        been on the board of the European Society for Primary
lecturer in family medicine at Uppsala University. In 2000, he   Care since its establishment in 1996 and now serves as the
accepted a position as a senior lecturer and researcher at the   society’s president. Professor Agréus is a member of the
Center for Family and Community Medicine in Stockholm.           Swedish Gastrointestinal Society and the Swedish Primary
   For the past decade, Professor Agréus has focused on          Care Society, and is a fellow of the American Gastrointestinal
population-based endoscopy studies. During this time, he         Association.
has developed an international network of collaborators            Lars Agréus is also a dedicated rural general practitioner.
from the fields of gastroenterology, pathology, microbiology,    He has served the same rural district since 1981, and is a
genetics, and psychoneuroimmunology. An example of               member of both national and international rural medicine
their work is the Kalixanda Study, an upper endoscopy            societies.
study that included endoscopies with biopsies, blood tests,

     Functional dyspepsia and functional heartburn: Natural history of symptoms in the general
     population and validity of Rome III upper gastrointestinal diagnostic criteria

      Background: Functional gastrointestinal disorders              Methods: The study builds on a series of postal
    (FGIDs) are common and usually life-long conditions          surveys of abdominal/gastrointestinal symptoms in
    that affect quality of life. Symptoms may fluctuate          the same adult random population sample (n ≅ 1400)
    over time. However, only a minority of people with           in the municipality of Östhammar, Sweden, conducted
    symptoms seek health care. A better understanding            in 1988, 1989, 1995, and (in a subsample) in 1996,
    of the long-term natural history of FGIDs requires           using the validated Abdominal Symptom Questionnaire
    population-based studies with years or even decades          (ASQ). Residents of the municipality ≥ 20 years and born
    of follow-up. Moreover, Rome III definitions of upper        on the 3rd, 12th, or 24th of each month plus surviving
    FGIDs have become the diagnostic standard but have           members of the original study population who have
    never been validated by esophagogastroduodenoscopy           moved elsewhere in Sweden will be mailed a further
    (EGD) in non-patients.                                       ASQ in spring 2011. Responders to the spring survey
                                                                 aged 20 to 80 years will be invited to endoscopy with
       Aims: First, to study the natural history of FGIDs,       biopsies in fall 2011. At the EGD visit, participants (n ≅
    especially functional heartburn (FH) and functional          800) will provide medical history; respond to the Rome
    dyspepsia (FD) over 23 years. Second, to validate            III questionnaire, the ASQ, and other questionnaires;
    the Rome III criteria for upper FGIDs using EGD with         and provide a blood sample for biomarker analysis.
    biopsies to rule out organic causes. To achieve these        Non-response studies will be performed for each study
    aims, we will use true population-based data with a          step.
    high participation rate and robust non-response data
    not biased by healthcare-seeking behavior.

                                               www . theromefoundation . org                                                       7
Program and Project uPdates

                                                          T     he Rome Foundation established an award in memory of Ray
                                                                E. Clouse, MD a gastroenterologist and scholar at Washington
                                                                University School of Medicine and a devoted member of the
                                                          Rome Foundation. Ray’s academic career spanned 27 years of
                                                          research, teachings and writings that has left an indelible mark in the
                                                          field of functional GI and motility disorders and of gastroenterology
                                                          in general.
                                                          This year, the Rome Foundation is pleased to offer three awards, two
                                                          for The Ray Clouse Prize for the Best Research Article on Functional
                                                          GI and Motility Disorders, 2010, and a third, new award entitled
                                                          The Ray Clouse Prize for the Most Cited Article on Functional GI and
                                                          Motility Disorders 2009. The Best Research Article prizes are being
                                                          awarded to Tamira K. Klooker MD for her paper, “The mast cell
                                                          stabilizer ketotifen decreases visceral hypersensitivity and improves
                                                          intestinal symptoms in patients with irritable bowel syndrome”
     Ray E. Clouse, MD                                    and to QiQi Zhou MD, PhD for her paper, “MicroRNA-29a regulates
                                                          intestinal membrane permeability in patients with irritable bowel
                                                          syndrome.” The Most Cited Article prize is being awarded to Siobhain
                                                          M. O’Mahony, PhD for her paper, “Early life stress alters behavior,
                                                          immunity, and microbiota in rats: implications for irritable bowel
                                                          syndrome and psychiatric illnesses.”

               Ray Clouse Prize for the Most Cited Article in
         Functional Gastrointestinal and Motility Disorders, 2009

                                           Siobhain M. O’Mahony, PhD (award recipient)
                                           with coauthors: Marchesi JR, Codling C, Ceolho AM, Quigley EM, Cryan JF, Dinan TG
                                           Early life stress alters behavior, immunity, and microbiota in rats: implications for
                                           irritable bowel syndrome and psychiatric illnesses. Biol Psychiatry 2009;65:263-7.

          BACKGROUND: Adverse early life events are associated with              RESULTS: The early life stress increased the number of fecal boli in
          a maladaptive stress response system and might increase the            response to a novel stress. Plasma corticosterone was increased
          vulnerability to disease in later life. Several disorders have         in the maternally separated animals. An increase in the systemic
          been associated with early life stress, ranging from depression        immune response was noted in the stressed animals after an in
          to irritable bowel syndrome. This makes the identification of          vitro lipopolysaccharide challenge. Increased visceral sensation
          the neurobiological substrates that are affected by adverse            was seen in the stressed group. There was an alteration of the
          experiences in early life invaluable.                                  fecal microbiota when compared with the control group.

          METHODS: The purpose of this study was to assess the effect of         CONCLUSIONS: These results show that this form of early life
          early life stress on the brain-gut axis. Male rat pups were stressed   stress results in an altered brain-gut axis and is therefore an
          by separating them from their mothers for 3 hours daily between        important model for investigating potential mechanistic insights
          postnatal days 2-12. The control group was left undisturbed with       into stress-related disorders including depression and IBS.
          their mothers. Behavior, immune response, stress sensitivity,
          visceral sensation, and fecal microbiota were analyzed.

 8                                                                     r ome foundation
                                                                                                      Program and Project uPdates

    Ray Clouse Prize for the Best Research Article on
Functional Gastrointestinal and Motility Disorders, 2010
                              This year two outstanding papers were chosen for this award

                                  Tamira K Klooker, MD (award recipient)
                                  with coauthors: Braak B, Koopman KE, Welting O, Wouters MM, van der Heide S,
                                  Schemann M, Bischoff SC, van den Wijngaard RM, Boeckstaens GE.
                                  The mast cell stabilizer ketotifen decreases visceral hypersensitivity and improves
                                  intestinal symptoms in patients with irritable bowel syndrome. Gut 2010;59:1213-21.
BACKGROUND: Mast cell activation is thought to be involved in        RESULTS: Ketotifen but not placebo increased the threshold for
visceral hypersensitivity, one of the main characteristics of the    discomfort in patients with IBS with visceral hypersensitivity. This
irritable bowel syndrome (IBS). A study was therefore undertaken     effect was not observed in normosensitive patients with IBS.
to investigate the effect of the mast cell stabiliser ketotifen on   Ketotifen significantly decreased abdominal pain and other IBS
rectal sensitivity and symptoms in patients with IBS.                symptoms and improved quality of life. The number of mast cells
METHODS: 60 patients with IBS underwent a barostat study to          in rectal biopsies and spontaneous release of tryptase were lower
assess rectal sensitivity before and after 8 weeks of treatment.     in patients with IBS than in healthy volunteers. Spontaneous
After the initial barostat, patients were randomised to receive      release of histamine was mostly undetectable but was slightly
ketotifen or placebo. IBS symptoms and health-related quality        increased in patients with IBS compared with healthy volunteers.
of life were scored. In addition, mast cells were quantified and     Histamine and tryptase release were not altered by ketotifen.
spontaneous release of tryptase and histamine was determined
                                                                     CONCLUSIONS: This study shows that ketotifen increases the
in rectal biopsies and compared with biopsies from 22 age- and
                                                                     threshold for discomfort in patients with IBS with visceral
gender-matched healthy volunteers.
                                                                     hypersensitivity, reduces IBS symptoms and improves health-
                                                                     related quality of life. Whether this effect is secondary to the
                                                                     mast cell stabilising properties of ketotifen or H(1) receptor
                                                                     antagonism remains to be further investigated. Trial Registration
                                                                     Number NTR39, ISRCTN22504486.

                                  QiQi Zhou, MD, PhD (award recipient)
                                  with coauthors: Souba WW, Croce CM, Verne GN
                                  MicroRNA-29a regulates intestinal membrane permeability in patients with irritable
                                  bowel syndrome. Gut 2010;59:775-84.

BACKGROUND: The molecular mechanisms underlying the                  RESULTS: A subset of patients with IBS (8/19, 42%) had increased
pathophysiology of irritable bowel syndrome (IBS) are poorly         intestinal membrane permeability and decreased glutamine
understood. One mechanism may involve increased intestinal           synthetase expression compared to patients with IBS normal
permeability that is reversed with glutamine supplementation.        membrane permeability, and to controls. Expression of miR-29a
Our goal was to evaluate the expression of glutamine synthetase      was increased in blood microvesicles, small bowel and colon tissues
and its complementary miRNA in blood microvesicles and gut           of IBS patients with increased intestinal membrane permeability.
tissues of IBS patients with increased intestinal membrane           Increased intestinal permeability was modulated by miR-29a which
permeability.                                                        has a complementary site in the 3'-UTR of the GLUL gene.

METHODS: We evaluated 19 diarrhoea-predominant IBS patients          CONCLUSIONS: The results support the conclusion that GLUL
and 10 controls for intestinal membrane permeability using the       regulates intestinal membrane permeability and miR-29a regulates
lactulose/mannitol method. miRNA expression was evaluated            both GLUL and intestinal membrane permeability. The data suggests
in blood microvesicles and gut tissue. To further confirm            that miR-29a effects on intestinal membrane permeability may be
the relationship between miRNA and glutamine synthetase              due to its regulation of GLUL. Targeting this signalling pathway could
expression, cell culture experiments were conducted. Glutamine       lead to a new therapeutic approach to the treatment of patients
synthetase was also evaluated in the gut tissues of patients.        with IBS, especially because small molecules that mimic or inhibit
                                                                     miRNA-based mechanisms are readily available.

                                                 www . theromefoundation . org                                                                9
Program and Project uPdates

                                  Rome Foundation Working team committee
                                  The role of the intestinal microbiota in
                                  functional gastrointestinal disorders – March 2011

                                  Magnus Simrén, MD, PhD

     The group was formed during the spring 2010 and had a start-up telephone
     conference in May 2010, where the aims of the working team were                m embers   Of the     W Orking t eam
     clarified and an outline for the publications was discussed. This outline
     was thereafter modified and finalized via e-mails in June 2010. The group
     members volunteered for the different tasks and a number of groups within        C hair
     the working team were formed based on the expertise of the members.
                                                                                      Magnus Simrén, MD, PhD
     The work was divided between the members and a timeline was decided              Gothenburg, Sweden
     (updated timeline, see below). Part of the members met at a face-to-face
     meeting in Boston at the International Neurogastroenterology and Motility        C O -C hair
     meeting in August 2010, and those who were not able attend participated
                                                                                      Giovanni Barbara, MD
     via telephone. During the autumn/winter 2010/2011, the different chapters        Bologna, Italy
     for the manuscript, as outlined below, have been prepared, and a first draft
     manuscript is currently being prepared. This will be discussed and finalized
     at a face-to-face meeting of the Working Team Group the day after Digestive      C liniCal
     Disease Week in Chicago. Thereafter, an internal review process within the
     team, as well as within the Rome Foundation, will be performed and the           Peter Whorwell, PhD
                                                                                      Manchester, UK
     goal is to have a manuscript to submit to a major gastroenterology journal
     early autumn 2011. Moreover, during this years UEGW in Stockholm, two            Brennan Spiegel, MD
     lectures, based on the work of this Working Team Group will be given at          Los Angeles, CA, USA
     a two-days symposium within the congress, entitled “Today’s science;
                                                                                      Robin Spiller, MD
     tomorrow’s medicine: Role of bacteria in health and disease”.                    Nottingham, UK
           ▪ To critically review the existing literature on                          t ranslatiOnal
             the role of gut microbiota in functional GI                              Stephen Vanner, MD
             disorders (FGIDs), with focus on clinical and                            Kingston, Canada
             translational aspects.                                                   Elena Verdu, MD, PhD
           ▪ Based on the literature search, provide                                  Hamilton, Canada
             recommendations how to implement the
             current knowledge into clinical practice, in                             b asiC /m iCrObiOlOgy
             order to improve the health of our patients.                             Erwin Zoetendal, MD
           ▪ Give recommendations for future work in                                  Wageningen, the Netherlands
             order to improve the current knowledge on                                Harry Flint, PhD
             the role of gut microbiota in functional GI                              Aberdeen, UK
           ▪ Produce an extensive background document
             including all the relevant references and
             information of relevance, as well as a
             clinically useful, review, submitted to one of
             the major scientific journals in our field.

10                                                              r ome foundation
                                                                                                Program and Project uPdates

A s s o c i at e s                             of          R ome
M      embership in the Associates of Rome program has more than doubled since the last
       newsletter! There are now 54 Associates including gastroenterologists, pediatricians,
primary care physicians, and psychotherapists. Joining is easy (and free), just visit www. Benefits include a discount on Rome
products and conferences, the bi-annual printed newsletter and quarterly e-newsletter,
Rome pin, and a Certificate of Association. Several Associates were recently able to register
at a discounted rate for the IBS – A Global Perspective Conference, held in Milwaukee,

The program best serves health care professionals and investigators. Patients are welcome to
join, but may also want to consider contacting IFFGD (International Foundation for Functional
Gastrointestinal Disorders, for more patient-centered information about life
with GI disorders.

                               Welcome Associates of Rome
         Shahab Abid, PhD                                  Lillian Ethapemi                        Mildret Quisbert
             Pakistan                                            England                                Bolivia
        Peyman Adibi, MD                                 Basem E. Eysa, MD                      Shaman Rajindrajith, MD
             Iran                                             Egypt                                   Sri Lanka
         Hamid Afshar, MD                                   Carla Flik, MD                          Yishai Ron, MD
               Iran                                          Netherlands                                 Israel
       Marc Beer-Gabel, MD                             Mojgan Forootan, MD                      Bengt Safsten, MD, PhD
              Israel                                           Iran                                    Sweden
             Sheila Bell                                 Jan Gambino, M.Ed                       Allison Siebecker, MD
              Scotland                                          USA                                        USA
       Ben Bradenham, MD                               Ali Gholamrezaei, MD                         Marconde Silva
              USA                                               Iran                                    Brazil
       Ragnar Breckan, MD                                    Mary Gross                               Erin Slater
            Norway                                             USA                                       USA
         Mohammed Butt                                    Shengxi Han, MD                          Rosa Soares, MD
             Qatar                                             China                                    Brazil
          Dan Carter, MD                                 William Hays, MD                         Christian Speer, MD
              Israel                                            USA                                       USA
      Jihong Chen, MD, PhD                               Michio Hongo, MD                          Ami Sperber, MD
              China                                            Japan                                    Israel
   Hamed Daghaghzadeh, MD                               Sandeep Jillella, MD                       Byron Theron, MD
            Iran                                              India                                       UK
       Nasser Daryani, PhD                               Ho Xuan Linh, MD                          Elisa Tiomny, MD
               Iran                                          Viet Nam                                     Israel
            Esther Dekel                                 Snezana Lukic, MD                         Serkan Torun, MD
               Israel                                         Serbia                                    Turkey
           Roy Dekel, MD                                  Joseph Lysy, MD                        Minh Minh Tran, MD
               Israel                                          Israel                                 Viet Nam
   Niranga Devanarayana, MD                              Alejandro Martinez                        Emily Tucker, MD
            Sri Lanka                                          Mexico                                     UK
      Thomas DuHamel, PhD                                 Sabrina Nery, MD                           Wei Wei, PhD
              USA                                               Brazil                                  China
          Collin Ellis, PhD                           Hong Ouyang, MD, PhD                         John Wyman, MD
                USA                                          China                                       USA
        Gulin Erdemir, MD                              Tatjana Puc Kous, MD                       Lee Yeong Yeh, MD
              Turkey                                          Slovenia                                 Malaysia

                                                 www . theromefoundation . org                                            11
     meetings and events

          Meet the experts
        How I manage a patient with a di cult
        case of…

                            with Javier Santos

                           with Magnus Simrén

             with André Smout

        Chairmen: Robin Spiller
                  Fernando Azpiroz

12                                r ome foundation
                                                                                                        meetings and events

                  IBS – The Global Perspective conference
                   Milwaukee, Wisconsin
                   April 6-7, 2011

T   he Rome Foundation and the World Gastroenterology
    Association convened an international symposium on
“IBS – The Global Perspective” that took place on April 6-7,
                                                                   workshops, one on cross-cultural clinical competence and
                                                                   the second on cross-cultural research competence. In the
                                                                   first, the participants witnessed and participated in role-play
2011 in Milwaukee, Wisconsin.                                      simulating real-life cross-cultural clinical situations.
The primary aim of the symposium was to bring together an          The conference also had a session with regulatory agency
international group of clinicians, scientists and researchers      representatives from the United States (FDA), Europe
with an interest in IBS and other functional GI disorders to       (EMEA) and Japan. This session focused on the conduct of
foster greater awareness of the multi-national, cross-cultural     multinational clinical trials including developing culturally
aspects of IBS, and update existing knowledge on similarities      appropriate study instruments and patient-reported
and differences at a global level. In terms of clinical practice   outcomes (PROs).
the focus was on greater awareness of the complexity of
working in a multicultural clinic, and the development clinical    The participants in this meeting expressed their feeling
skills to function successfully in that milieu. This included      that it was unique and stimulating with an excellent faculty.
awareness of patient and physician explanatory models of           There was a feeling that it could energize the functional GI
illness and their cultural associations. In terms of research      community to develop new initiatives on an international
the focus was on improving the quality of multinational            scale.
clinical trials and research, and establish international
research networks.                                                 As one outcome of this meeting the Rome Foundation
                                                                   has established a working team on multinational, cross-
The participants heard talks from a spectrum of speakers           cultural research with a mandate to develop guidelines for
that included gastroenterologists from around the world,           future research projects, to foster international research
and medical anthropologists and psychiatrists who provided         networks, and to plan and implement a global study on IBS
insights from perspectives that are not usually represented        epidemiology.
in meetings of gastroenterologists. There were two

                              Special thanks to our conference sponsors
                                        Ironwood Pharmaceuticals, Inc.
                                             Procter & Gamble, Co.
                                   Takeda Pharmaceuticals North America, Inc.
                                         Zeria Pharmaceuticals Co., Ltd.

                                                www . theromefoundation . org                                                        13
     meetings and events

        The Fourth Annual Rome Foundation — AGA Institute
        Lectureship at Digestive Disease Week 2011
        Sunday May 8, 2011
        10:30 - 12:00
        E 451B Lakeside Level 4
        Mc Cormick Place, Chicago, IL                                           Agenda
                                                                                  The Role of Neurogenesis in
        The Rome Foundation and the American                                      the Brain
        Gastroenterological Association (AGA) were
        pleased to announce their 4th annual lectureship                          with Tarique Perera, MD
        at Digestive Diseases Week (DDW). The                                     Columbia University
        lectureship is designed to address broad aspects
        of health care that are relevant to digestive
        diseases and the functional GI disorders.
        Learning Objectives:
            1.   To discuss the suppression of                                    The Role of Neurognesis in the
                 neurogenesis in the hippocampus                                  Enteric Nervous System and its
                 in depression and the potential                                  implications for Functional GI
                 restoration with antidepressants                                 and Motility disorders
            2.   To review neurogenesis of enteric                                with Michael D. Gershon, MD
                 nerves and their role in gut                                     Columbia University
            3.   To explain the relevance of
                 neurogenesis in the central
                 and enteric nervous systems to
                 functional GI and motility disorders

                                                             Digestive Disease Week
                                                             Booth 2354

                                                             The Rome Foundation encourages all members
                                                             and sponsors to visit our booth at DDW. This year
                                                             we are proud to offer the Diagnostic Algorithms
                                                             for Common Gastrointestinal Symptoms on
                                                             CD-ROM. We will also be offering copies of
                                                             the Rome III book, published in 2006, as well
                                                             as the Computer-Based Learning Program and
                                                             Understanding the Irritable Gut, by W. Grant
         May 7-10, 2011                                      Thompson, MD. New this year will be details
                                                             about our latest program – Associates of
         McCormick Place                                     Rome. A listing of benefits of this initiative and
         Chicago, IL                                         enrollment forms will be available at our booth.
                                                             There will also be many handouts and other
                                                             research materials available. Be sure to visit us
                                                             at booth 2354!!

14                                                         r ome foundation

                                Patient Perspective:
                                An Update from the International Foundation for
                                Functional Gastrointestinal Disorders (IFFGD)

                                Dane Christiansen
                                Development Coordinator

2011 marks IFFGD’s 20th year of service to the functional             To further advance our legislative priorities, IFFGD will be
gastrointestinal and motility disorders (FGIMDs) community.           hosting its Capitol Hill Advocacy Day at the Phoenix Park Hotel
Over the past two decades, much progress has been made                in Washington, DC on Tuesday, June 14th and Wednesday,
through efforts to advocate, raise awareness, and advance             June 15th, 2011. This event is open to patients, physicians, and
research into FGIMDs. We are humbled and sincerely grateful           anyone who wants to make a difference; it is also free of charge
to all who have participated in these efforts.                        so please contact us and make your plans to attend today.
To honor the dedication of our volunteers and apply their             Research & Awareness
contributions to maximum effect, IFFGD has launched a bold            Through the Digestive Health Alliance many individuals have
new initiative known as the Digestive Health Alliance™ or             already begun conducting volunteer-led fundraisers, such as
DHA. This grassroots network will provide affected individuals        walk-a-thons and letter writing campaigns to bolster the IFFGD’s
in towns and cities across America with the tools they need to        research fund and raise awareness of FGIMDs. The Foundation
take action in support of the field. In this regard, DHA activities   will also be expanding our efforts in these areas by hosting a
will focus on advocating on Capitol Hill, raising awareness, and      benefit regatta at the Kenosha Yacht Club in Kenosha, WI on
donating or fundraising for research.                                 August 20th, 2011. In addition to the boat races, this event will
                                                                      feature a beach party cook-out with live entertainment and
Advocacy                                                              special guests.
IFFGD and DHA grassroots advocates continue to conduct
outreach to Members of Congress in support of a Legislative           IFFGD continues to provide support for a children’s FGIMD
Agenda that stresses increasing the federal commitment to             research initiative, and peer-reviewed research awards. Through
FGIMDs research and improving patient care. Since the 112th           the Digestive Health Alliance, we are looking forward to securing
Congress convened in January of this year, meaningful progress        additional funds and expanding both of these programs.
has been made in the following areas:
  • Defending federal funding for the National Institutes of          As the flagship event of our continuous effort to advance
    Health (NIH) and working to secure a funding increase to          scientific understanding of FGIMDs, the 9th International
    bring the agency’s overall level of support to $35 billion in     Symposium on Functional Gastrointestinal Disorders was held
    Fiscal Year 2012.                                                 on April 8–10, 2011 at the Pfister Hotel in Milwaukee, WI. The
  • Introduction and passage of a bill initially drafted by           meeting was once again jointly sponsored by the University
    IFFGD to bolster support for critical research activities and     of Wisconsin School of Medicine and Public Health, Office of
    open new avenues of research support, the Functional              Continuing Professional Development, and IFFGD. Participation
    Gastrointestinal and Motility Disorders Research                  in this event continues to grow and reflect a growing interest in
    Enhancement Act.
  • Including “functional gastrointestinal disorders” on the          the field. Given the success of this year’s event, we are already
    annual list of conditions deemed eligible for study through       looking forward to the next Symposium in 2013, and we hope
    the Department of Defense’s Peer-Reviewed Medical                 you are too!
    Research Program.
  • Passage of a bipartisan bill to increase financial support
    for pediatric research networks through NIH, the Pediatric
    Research Consortium Establishment Act (H.R. 1080).

                                                    www . theromefoundation . org                                                         15
     Please Visit our Rome Foundation Booth #2354 at DDW in Chicago
16                              r ome foundation

                                                                                                        contact information:
                                                                                                             Randall D. Avram
                                                                                           Kilpatrick	Townsend	&	Stockton,	LLP
                                                                                              3737 Glenwood Avenue, Ste. 400
                                                                                                            Raleigh, NC 27612
                                                                                                               (919)	420-1812

                                        Randall D. Avram

We are pleased to introduce Randall D. Avram as our                Carolina, Washington, Sweden, Dubai, Japan and Taipei.
Counsel for the Rome Foundation. In this capacity he
will advise the President and Board on issues relating to          Randy concentrates his time in labor and employment law
personnel and Business related issues.                             and	is	chairman	of	the	Labor	and	Employment	Department.	
                                                                   Randy	has	been	named	Best	Lawyer	in	America(r)	and	as	
Randall D. Avram is a partner in the multinational,                Top	100	Lawyers	by	"North	Carolina	Magazine."
multipractice	law	firm	of	Kilpatrick	Townsend	&	Stockton	LLP	
(Kilpatrick	 Townsend).	 KilpatrickTownsend	 serves	 clients	      Since joining us, Randy has helped us develop an effective
in	the	areas	of	intellectual	property,	business	and	finance,	      copyright and licensing Policy and has advised us on
construction and infrastructure, government, litigation            business relations relative to our sponsors and personnel.
and	 labor	 and	 employment	 from	 18	 offices	 in	 California,	   We are most grateful for his interest in helping us.
Colorado, District of Columbia, Georgia, New York, North

     Algorithm Publication and Access

                                                                   The Rome Foundation Diagnostic Algorithms
                                                                   for Common Gastrointestinal Symptoms are
                                                                   now available via the following:
                                                                       •	 A CD-ROM of all 15 Algorithms is now
                                                                          available and will be given out at all
                                                                          Rome Foundation booths.
                                                                       •	 The interactive webpage on the Rome
                                                                          Foundation website will now contain all
                                                                          15 Diagnostic Algorithms.
                                                                       •	 A Spanish version of the Algorithms
                                                                          was published in November 2010 in the
                                                                          Mexican Journal of Gastroenterology.
                                                                       •	 For free download as a PDF from our
                                                                          website and the AJG website, www.

                                                 www . theromefoundation . org                                                   17

                               Rome and AGA Forge Collaboration

                                Dianne Bach
                                Senior Vice President
                                AGA Institute

     O         ur mutually beneficial educational collaboration with the Rome Foundation continues. To recap, we are
     excited to conduct our fifth joint lecture series at DDW to shine a spotlight on the importance of research, clinical
     education and physician-patient communications related to functional GI disorders. This year our lecture will take
     place on Sunday, May 8, from 10:30am to 12 noon in Room E451A of the Convention Center and will feature Tarique
     Perera, MD, assistant professor in clinical psychiatry, and Michael D. Gershon, MD, professor of pathology and cell
     biology, to provide a comprehensive overview of The Role of Neurogenesis in the Brain and Gut and its Implications
     for Functional GI and Motility Disorders. Both internationally renowned experts teach at Columbia University in New
     York. We’ve had stellar turn out for these lectures so I hope you can mark it on your schedule to attend.

     We will also continue providing marketing support for two Rome created educational activities—the Rome III book
     and the Computer Based Learning Program. I hope you have seen our colorful advertisements in Gastroenterology,
     Clinical Gastroenterology and Hepatology and in GI and Hepatology News. We want AGA members to be aware of
     and purchase these valuable resources at a nice discount!

     A new and exciting joint activity is starting to take shape thanks to some preliminary educational support for Forest
     Laboratories, Inc. It is a unique communication skills workshop designed to improve the dialogue between physicians
     and patients that have functional GI disorders. In order to launch this workshop, we have asked for additional
     educational support from other sources and are awaiting a response. If our industry friends are reading this and
     want to learn more, please don’t hesitate to contact me ( or Dr. Doug Drossman for further details
     and how you can help.

     As a member of the Rome Foundation Advisory Board, I have truly enjoyed my friendship with the leaders and the
     staff of the Rome Foundation and look forward to continuing to grow our relationship in 2011-12 and beyond.

18                                                      r ome foundation

We are pleased tO prOvide fOr yOu in this and future issues artiCles that have been published
that highlight the rOme Criteria.

1:	 Hellström	 PM,	 Saito	 YA,	 Bytzer	 P,	 Tack	 J,	 Mueller-     8:	 Czyzewski	 DI,	 Lane	 MM,	 Weidler	 EM,	 Williams	 AE,	
Lissner	S,	Chang	L.	Characteristics	of	Acute	Pain	Attacks	         Swank PR, Shulman RJ. The interpretation of Rome III
in Patients With Irritable Bowel Syndrome Meeting Rome             criteria and method of assessment affect the irritable
III Criteria. Am J Gastroenterol. 2011 Mar 29. [Epub ahead         bowel	 syndrome	 classification	 of	 children.	 Aliment	
of print] PubMed PMID: 21448146.                                   Pharmacol	 Ther.	 2011	 Feb;33(3):403-11.	 doi:	 10.1111/
                                                                   j.1365-2036.2010.04535.x. Epub 2010 Dec 8. PubMed
                                                                   PMID: 21138454.
2:	 Van	 Oudenhove	 L,	 Holvoet	 L,	 Vandenberghe	 J,	 Vos	
R, Tack J. Do we have an alternative for the Rome III
gastroduodenal symptom-based subgroups in functional               9:	 Stanghellini	 V,	 Frisoni	 C.	 Editorial:	 Reflux,	 dyspepsia,	
gastroduodenal disorders? A cluster analysis approach.             and	 Rome	 III	 (or	 Rome	 IV?).	Am	 J	 Gastroenterol.	 2010	
Neurogastroenterol Motil. 2011 Mar 30. doi: 10.1111/               Dec;105(12):2632-4.	PubMed	PMID:	21131930.
j.1365-2982.2011.01703.x. [Epub ahead of print] PubMed
PMID: 21447145.
                                                                   10:	Hsu	YC,	Liou	JM,	Yang	TH,	Hsu	WL,	Lin	HJ,	Wu	HT,	
                                                                   Lin	 JT,	 Wang	 HP,	 Wu	 MS.	 Proton	 pump	 inhibitor	 versus	
3:	Tam	YH,	Chan	KW,	To	KF,	Cheung	ST,	Mou	JW,	Pang	                prokinetic therapy in patients with functional dyspepsia: is
KK,	 Wong	 YS,	 Sihoe	 JD,	 Lee	 KH.	 Impact	 of	 Pediatric	       therapeutic response predicted by Rome III subgroups? J
Rome III Criteria of Functional Dyspepsia on the Diagnostic        Gastroenterol.	2011	Feb;46(2):183-90.	Epub	2010	Oct	19.	
Yield of Upper Endoscopy and Predictors for a Positive             PubMed PMID: 20957498.
Endoscopic Finding. J Pediatr Gastroenterol Nutr. 2011
Apr;52(4):387-91.	PubMed	PMID:	21415670.
                                                                   11:	 Xiao	 YL,	 Peng	 S,	 Tao	 J,	 Wang	 AJ,	 Lin	 JK,	 Hu	 PJ,	
                                                                   Chen MH. Prevalence and symptom pattern of pathologic
4:	Savarino	E,	Marabotto	E,	Zentilin	P,	Frazzoni	M,	Sammito	       esophageal	acid	reflux	in	patients	with	functional	dyspepsia	
G,	 Bonfanti	 D,	 Sconfienza	 L,	 Assandri	 L,	 Gemignani	 L,	     based on the Rome III criteria. Am J Gastroenterol. 2010
Malesci A, Savarino V. The added value of impedance-pH             Dec;105(12):2626-31.	Epub	2010	Sep	7.	PubMed	PMID:	
monitoring to Rome III criteria in distinguishing functional       20823838.
heartburn	 from	 non-erosive	 reflux	 disease.	 Dig	 Liver	
Dis. 2011 Mar 2. [Epub ahead of print] PubMed PMID:
21376679.                                                          12:	 Chogle	A,	 Dhroove	 G,	 Sztainberg	 M,	 Di	 Lorenzo	 C,	
                                                                   Saps M. How reliable are the Rome III criteria for the
                                                                   assessment of functional gastrointestinal disorders in
5: Abid S, Siddiqui S, Jafri W. Discriminant value of Rome III     children?	 Am	 J	 Gastroenterol.	 2010	 Dec;105(12):2697-
questionnaire in dyspeptic patients. Saudi J Gastroenterol.        701. Epub 2010 Aug 31. PubMed PMID: 20808296.
2011	Mar-Apr;17(2):129-33.	PubMed	PMID:	21372351.

                                                                   13: Devanarayana NM, Adhikari C, Pannala W, Rajindrajith
6:	 Ohara	 S,	 Kawano	 T,	 Kusano	 M,	 Kouzu	 T.	 Survey	          S. Prevalence of functional gastrointestinal diseases
on the prevalence of GERD and FD based on the                      in	 a	 cohort	 of	 Sri	 Lankan	 adolescents:	 comparison	
Montreal	 definition	 and	 the	 Rome	 III	 criteria	 among	        between Rome II and Rome III criteria. J Trop Pediatr.
patients presenting with epigastric symptoms in Japan. J           2011	 Feb;57(1):34-9.	 Epub	 2010	 Jun	 4.	 PubMed	 PMID:	
Gastroenterol. 2011 Feb 26. [Epub ahead of print] PubMed           20525779.
PMID: 21359521.

7:	 Reisswitz	 PS,	 Mazzoleni	 LE,	 Sander	 GB,	 Francisconi	
CF. Portuguese validation of the Rome III diagnostic
questionnaire for functional dyspepsia. Arq Gastroenterol.
2010	Dec;47(4):354-60.	PubMed	PMID:	21225145.

                                                 www . theromefoundation . org                                                           19
abOut the                                                    rome Board of directors
rOme fOundatiOn
The Rome Foundation is an
independent	not	for	profit	501(c)	3	
organization	that	provides	support	for	
activities	designed	to	create	scientific	
data and educational information to
assist in the diagnosis and treatment
of functional gastrointestinal disorders
(FGIDs).	Our	mission	is	to	improve	
the lives of people with functional GI
Over the last 20 years, the Rome
organization	has	sought	to	legitimize	
and update our knowledge of the
FGIDs. This has been accomplished
by bringing together scientists and
clinicians from around the world to
classify and critically appraise the
science of gastrointestinal function
and dysfunction. This knowledge             From left to right:	(Front	row):	Nicholas	Talley,	John	Kellow,	Doug	Drossman,	
permits clinical scientists to make         William	Whitehead,	Lin	Chang;	(Back	row):	Jan	Tack,	Enrico	Corazziari,	
recommendations for diagnosis and           Fernando	Azpiroz,	Robin	Spiller,	William	D.	Chey
treatment that can be applied in
research and clinical practice.
The Rome Foundation is committed
to the continuous development,
legitimization	and	preservation	of	the	
                                                                            s Ponsors
field	of	FGIDs	through	science-based	
activities. We are inclusive and
collaborative, patient-centered,                           astellas Pharma, inc.
innovative and open to new ideas.
The goals of the Rome Foundation
                                                    astraZeneca Pharmaceuticals, lP
are to:
 •	Promote clinical recognition and                      forest laBoratories, inc.
   legitimization	of	the	functional	GI	
   disorders                                           furiex Pharmaceuticals, inc.
 •	Develop	a	scientific	understanding	
   of their pathophysiological                       ironwood Pharmaceuticals, inc.
 •	Optimize	clinical	management	for	
   patients with FGIDs
                                                       lexicon Pharmaceuticals, inc.
                                                   shire-movetis Pharmaceuticals, inc.
                                                          Procter & gamBle, co.
                                                      Prometheus laBoratories, inc.
                                                        salix Pharmaceuticals, inc.
                                                          sanofi-aventis grouPe
         visit us on                                  synergy Pharmaceuticals, inc.
         the weB at                             takeda Pharmaceuticals north america, inc.                          Zeria Pharmaceuticals co., ltd.

                                                      r ome foundation

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